{"id":60880,"date":"2026-03-24T13:04:02","date_gmt":"2026-03-24T05:04:02","guid":{"rendered":"https:\/\/flcube.com\/?p=60880"},"modified":"2026-03-24T13:07:31","modified_gmt":"2026-03-24T05:07:31","slug":"remegen-secures-fourth-nmpa-approval-for-disitamab-vedotin-her2-low-breast-cancer-with-liver-metastases-indication-expands-adc-franchise","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=60880","title":{"rendered":"RemeGen Secures Fourth NMPA Approval for Disitamab Vedotin \u2013 HER2\u2011Low Breast Cancer with Liver Metastases Indication Expands ADC Franchise"},"content":{"rendered":"\n

RemeGen Co., Ltd.<\/strong> (SHA: 688331<\/a>, HKG: 9995<\/a>) announced NMPA approval<\/strong> for a new indication<\/strong> of disitamab vedotin (RC48)<\/strong> \u2013 its HER2\u2011targeting antibody\u2011drug conjugate (ADC)<\/strong> \u2013 now approved for HER2\u2011low expressing breast cancer patients with liver metastases<\/strong> who have progressed after prior systemic therapy. This marks the fourth NMPA nod<\/strong> for China’s first domestically developed ADC<\/strong>, achieving full HER2 expression coverage<\/strong> (IHC 3+, IHC 2+\/ISH+, IHC 2+\/ISH\u2011, IHC 1+) in the liver metastases breast cancer population<\/strong>.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Product<\/strong><\/td>Disitamab vedotin (RC48) \u2013 HER2\u2011targeted ADC<\/td><\/tr>
Company<\/strong><\/td>RemeGen Co., Ltd. (HKG: 9995)<\/td><\/tr>
New Indication<\/strong><\/td>HER2\u2011low (IHC 1+ or IHC 2+\/ISH\u2011) unresectable\/metastatic breast cancer with liver metastases<\/strong><\/td><\/tr>
Patient Criteria<\/strong><\/td>Prior systemic therapy in metastatic setting, or relapse \u226412 months post\u2011adjuvant chemotherapy<\/td><\/tr>
Approval Basis<\/strong><\/td>Phase III RC48\u2011C012 trial (randomized, open\u2011label, parallel\u2011controlled, multicenter)<\/td><\/tr>
Strategic Significance<\/strong><\/td>Full HER2 expression coverage<\/strong> for breast cancer liver metastases; fourth NMPA approval<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Approved Indications Portfolio \u2013 RC48<\/h2>\n\n\n\n
Approval Date<\/th>Indication<\/th>HER2 Status<\/th>Tumor Type<\/th><\/tr><\/thead>
2021<\/strong><\/td>HER2\u2011overexpressing locally advanced\/metastatic gastric cancer<\/td>IHC 3+ or 2+\/ISH+<\/td>Gastric<\/td><\/tr>
2021<\/strong><\/td>HER2\u2011overexpressing locally advanced\/metastatic urothelial carcinoma<\/td>IHC 3+ or 2+\/ISH+<\/td>Urothelial<\/td><\/tr>
2023<\/strong><\/td>Advanced HER2\u2011positive breast cancer with liver metastases<\/td>IHC 3+ or 2+\/ISH+<\/td>Breast<\/td><\/tr>
2026<\/strong><\/td>HER2\u2011low breast cancer with liver metastases<\/strong><\/td>IHC 1+ or 2+\/ISH\u2011<\/strong><\/td>Breast<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Evidence \u2013 RC48\u2011C012 Phase III<\/h2>\n\n\n\n
Study Element<\/th>Detail<\/th>Clinical Outcome<\/th><\/tr><\/thead>
Design<\/strong><\/td>Randomized, open\u2011label, parallel\u2011controlled, multicenter<\/td>Robust comparative efficacy data<\/td><\/tr>
Population<\/strong><\/td>HER2\u2011low breast cancer with liver metastases<\/td>High\u2011unmet\u2011need subset (poor prognosis)<\/td><\/tr>
Prior Therapy<\/strong><\/td>\u22651 systemic therapy (metastatic) or relapse \u226412 months post\u2011adjuvant<\/td>Heavily pretreated population<\/td><\/tr>
Primary Result<\/strong><\/td>Favorable efficacy vs. control<\/td>Supports approval in HER2\u2011low segment<\/td><\/tr>
Safety Profile<\/strong><\/td>Manageable toxicity<\/td>Consistent with established RC48 profile<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Market Impact & Strategic Positioning<\/h2>\n\n\n\n
Dimension<\/th>HER2\u2011Low Breast Cancer Landscape<\/th>RC48 Position<\/th><\/tr><\/thead>
Biomarker Prevalence<\/strong><\/td>~45\u201155% of breast cancers are HER2\u2011low (IHC 1+ or 2+\/ISH\u2011)<\/td>Expanded addressable market beyond HER2\u2011positive (15\u201120% of cases)<\/td><\/tr>
Liver Metastases Significance<\/strong><\/td>Occurs in 40\u201150% of metastatic breast cancer; associated with poor survival<\/td>Targeted indication addresses high\u2011risk population with unmet need<\/td><\/tr>
Standard of Care<\/strong><\/td>Chemotherapy; CDK4\/6 inhibitors + endocrine therapy (HR+ subset); limited ADC options<\/td>First approved HER2\u2011targeted therapy for HER2\u2011low with liver mets in China<\/td><\/tr>
Competitive Dynamics<\/strong><\/td>Trastuzumab deruxtecan (DS\u20118201, Daiichi\/AZ) approved HER2\u2011low breast cancer globally; not yet China\u2011approved for this indication<\/td>China first\u2011mover advantage<\/strong> in HER2\u2011low liver metastases segment<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Commercial & Strategic Outlook<\/h2>\n\n\n\n